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OBJECTIVES: We aimed to assess the healthcare costs and impact on the economy at large arising from emergency medical services (EMS) treated non-traumatic shock. DESIGN: We conducted a population-based cohort study, where EMS-treated patients were individually linked to hospital-wide and state-wide administrative datasets. Direct healthcare costs (Australian dollars, AUD) were estimated for each element of care using a casemix funding method. The impact on productivity was assessed using a Markov state-transition model with a 3-year horizon. SETTING: Patients older than 18 years of age with shock not related to trauma who received care by EMS (1 January 2015-30 June 2019) in Victoria, Australia were included in the analysis. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome assessed was the total healthcare expenditure. Secondary outcomes included healthcare expenditure stratified by shock aetiology, years of life lived (YLL), productivity-adjusted life-years (PALYs) and productivity losses. RESULTS: A total of 21 334 patients (mean age 65.9 (±19.1) years, and 9641 (45.2%) females were treated by EMS with non-traumatic shock with an average healthcare-related cost of $A11 031 per episode of care and total cost of $A280 million. Annual costs remained stable throughout the study period, but average costs per episode of care increased (Ptrend=0.05). Among patients who survived to hospital, the average cost per episode of care was stratified by aetiology with cardiogenic shock costing $A24 382, $A21 254 for septic shock, $A19 915 for hypovolaemic shock and $A28 057 for obstructive shock. Modelling demonstrated that over a 3-year horizon the cohort lost 24 355 YLLs and 5059 PALYs. Lost human capital due to premature mortality led to productivity-related losses of $A374 million. When extrapolated to the entire Australian population, productivity losses approached $A1.5 billion ($A326 million annually). CONCLUSION: The direct healthcare costs and indirect loss of

BACKGROUND: Most people with mental health problems do not seek help, with delays of even decades in seeking professional help. Lack of engagement with professional mental health services can lead to poor outcomes and functional impairment. However, few effective interventions have been identified to improve help-seeking in adults, and those that exist are not widely implemented to deliver public health impact. Co-designing interventions with people with lived experience of mental ill-health and other relevant stakeholders is critical to increase the likelihood of uptake and engagement with these programs. OBJECTIVE: This study aims to (1) test the effectiveness of a co-designed help-seeking program on increasing professional help-seeking intentions in employees in a workplace setting; (2) determine whether the program reduces mental illness stigma and improves help-seeking intentions and behavior, mental health literacy, mental health symptoms, and work and activity functioning relative to the control condition; (3) explore factors that facilitate broader implementation of the co-designed program; and (4) explore the cost-effectiveness of the co-designed program compared to the control condition over 6 months. METHODS: A 2-arm cluster randomized controlled trial will be conducted (target sample: N=900 from 30 to 36 workplaces, with n=25 to 35 participants per workplace). The trial will compare the relative effectiveness of an enhanced interactive program (intervention condition) with a standard psychoeducation-alone program (active control condition) on the primary outcome of professional help-seeking intentions as measured by the General Help-Seeking Questionnaire. Secondary outcomes include the impact on mental illness stigma; mental health literacy; help-seeking attitudes and behavior; work and activity functioning; quality of life; and symptoms of mental ill-health including depression, anxiety, and general psychological distress. RESULTS: Facilitators of and r

OBJECTIVES: To critically examine the methods used for full economic evaluations of preventive interventions for dental caries and periodontitis. METHODS: Published literature post-2000 was searched to April 2021. Based on a developed intervention classification framework for dental caries and periodontitis, only universal, selective or indicated interventions were included in this review. The Drummond 10-point checklist was used for quality appraisal. RESULTS: Of 3,007 unique records screened for relevance, 73 studies were reviewed. Most model-based studies (61/73) used cost-effectiveness analysis (49%) or cost-benefit analysis (28%). Trial-based studies (16/73) commonly used cost-effectiveness analysis (59%). Four studies used both economic evaluation methods. Sixty-four papers (88%) were on dental caries, eight papers (11%) focused on periodontitis, and one paper (1%) included both oral diseases; 72% of model-based and 82% of trial-based studies were of good quality. The most frequently investigated dental caries preventive interventions were water fluoridation (universal intervention; cost-saving or cost-effective), fissure sealant and fluoride varnish (selective and indicated interventions; cost-effectiveness outcomes were inconsistent). Supportive periodontal therapy with oral health education (indicated intervention; cost-effective) was the most frequently evaluated preventive intervention for periodontitis. Thirty percent of studies with a time horizon > 1 year did not apply an appropriate discount rate and 26% did not comprehensively discuss other important considerations beyond the technical analysis. CONCLUSIONS: Generic health outcome measures should be incorporated for economic evaluations on preventive interventions for dental caries and periodontitis, and an increased focus to prevent periodontitis using economic evaluation methods is needed to inform resource allocation and policy decision-making.

BACKGROUND: Prior self-harm represents the most significant risk factor for future self-harm or suicide. AIM: To evaluate the cost-effectiveness of a theoretical brief aftercare intervention (involving brief follow-up contact, care coordination and safety planning), following a hospital-treated self-harm episode, for reducing repeated self-harm within the Australian context. METHOD: We employed economic modelling techniques to undertake: (a) a return-on-investment analysis, which compared the cost-savings generated by the intervention with the overall cost of implementing the intervention; and (b) a cost-utility analysis, which compared the net costs of the intervention with health outcomes measured in quality-adjusted life years (QALYs). We considered cost offsets associated with hospital admission for self-harm and the cost of suicide over a period of 10 years in the base case analysis. Uncertainty and one-way sensitivity analyses were also conducted. RESULTS: The brief aftercare intervention resulted in net cost-savings of AUD$7.5 M (95% uncertainty interval: -56.2 M to 15.1 M) and was associated with a gain of 222 (95% uncertainty interval: 45 to 563) QALYs over a 10-year period. The estimated return-on-investment ratio for the intervention's modelled cost in relation to cost-savings was 1.58 (95% uncertainty interval: -0.17 to 5.33). Eighty-seven per cent of uncertainty iterations showed that the intervention could be considered cost-effective, either through cost-savings or with an acceptable cost-effectiveness ratio of 50 000 per QALY gained. The results remained robust across sensitivity analyses. CONCLUSIONS: A theoretical brief aftercare intervention is highly likely to be cost-effective for preventing suicide and self-harm among individuals with a history of self-harm.

PURPOSE: This study explored differences in self-reported responses and the psychometric performance of the composite EQ-5D-5L anxiety/depression (A/D) dimension compared with a split version of the dimension where 'anxiety' and 'depression' are measured separately. METHODS: People with anxiety and/or depression who visited the Amanuel Mental Specialized Hospital in Ethiopia completed the standard EQ-5D-5L with the added subdimensions. Correlation analysis was used to examine convergent validity with validated measures of depression (PHQ-9) and anxiety (GAD-7), while ANOVA was used to assess known-groups' validity. Agreement between ratings for composite and split dimensions was compared using percent agreement and Cohen's Kappa, while the proportion of 'no problems' reports was compared using the chi-square test. Discriminatory power analysis was undertaken using the Shannon index (H') and Shannon Evenness index (J'). Open-ended questions explored participants' preferences. RESULTS: Of the 462 respondents, 30.5% reported no problems with the composite A/D, while 13.2% reported no problems on both subdimensions. Agreement between ratings for composite and split dimensions was highest for respondents with comorbid anxiety and depression. The depression subdimension had higher correlation with PHQ-9 (r = 0.53) and GAD-7 (r = 0.33) than the composite A/D dimension (r = 0.36 and r = 0.28, respectively). The split subdimensions and composite A/D could adequately differentiate respondents based on their severity of anxiety or depression. Slightly better informativity was observed in EQ-4D-5L + anxiety (H' = 5.4; J' = 0.47) and EQ-4D-5L + depression (H' = 5.31; J' = 0.46) than EQ-5D-5L (H' = 5.19; J' = 0.45). CONCLUSIONS: Adopting two subdimensions within the EQ-5D-5L tool appears to perform slightly better than the standard EQ-5D-5L.

OBJECTIVES: The objective of this study was to compare the concurrent and construct validity, as well as the sensitivity of 5 multiattribute utility instruments (MAUIs), including the Assessment of Quality of Life-6D (AQoL-6D), EQ-5D-Y, Health Utilities Index (HUI)-2 and HUI-3, and the Child Health Utility 9D, 1 generic pediatric quality of life instrument, with 3 routinely collected outcome measures in Australian mental health services (Strengths and Difficulties Questionnaire, Clinical Global Assessment Scale [CGAS] and the Health of the Nation Outcome Scale for Children and Adolescents) in children and adolescents diagnosed of internalizing (eg, anxiety/depression), externalizing (eg, attention deficit hyperactivity disorder/conduct disorders), and trauma/stress related mental disorders. METHODS: A cross-sectional survey of measures, including demographic and basic treatment information, in children/adolescents recruited via 5 child and youth mental health services in Queensland and Victoria, Australia. Measures were either proxy or self-report completed, the CGAS and the Health of the Nation Outcome Scale for Children and Adolescents were clinician completed. RESULTS: The sample included 426 participants and had a mean age of 13.7 years (range 7-18 years). Utilities (as calculated from MAUIs) were generally lower in older adolescents and those with internalizing disorders. All MAUIs and self-reported clinical measures significantly correlated with each other (absolute correlation range 0.40-0.90), with the AQoL-6D showing generally higher levels of correlations. Correlations between the MAUIs and clinician/proxy-reported measures were weak, regardless of diagnosis (absolute correlation range 0.09-0.47). Generally, EQ-5D-Y, HUI-2, and AQoL-6D were more sensitive than Child Health Utility 9D and HUI-3 when distinguishing between different severities according to clinician-assessed CGAS (effect size range 0.17-0.84). CONCLUSIONS: The study showed that the commonly

Background: Relapse is a major determinant of outcome for people with a diagnosis of schizophrenia. Early warning signs frequently precede relapse. A recent Cochrane Review found low-quality evidence to suggest a positive effect of early warning signs interventions on hospitalisation and relapse. Objective: How feasible is a study to investigate the clinical effectiveness and cost-effectiveness of a digital intervention to recognise and promptly manage early warning signs of relapse in schizophrenia with the aim of preventing relapse? Design: A multicentre, two-arm, parallel-group cluster randomised controlled trial involving eight community mental health services, with 12-month follow-up. Settings: Glasgow, UK, and Melbourne, Australia. Participants: Service users were aged > 16 years and had a schizophrenia spectrum disorder with evidence of a relapse within the previous 2 years. Carers were eligible for inclusion if they were nominated by an eligible service user. Interventions: The Early signs Monitoring to Prevent relapse in psychosis and prOmote Wellbeing, Engagement, and Recovery (EMPOWER) intervention was designed to enable participants to monitor changes in their well-being daily using a mobile phone, blended with peer support. Clinical triage of changes in well-being that were suggestive of early signs of relapse was enabled through an algorithm that triggered a check-in prompt that informed a relapse prevention pathway, if warranted. Main outcome measures: The main outcomes were feasibility of the trial and feasibility, acceptability and usability of the intervention, as well as safety and performance. Candidate co-primary outcomes were relapse and fear of relapse. Results: We recruited 86 service users, of whom 73 were randomised (42 to EMPOWER and 31 to treatment as usual). Primary outcome data were collected for 84% of participants at 12 months. Feasibility data for people using the smartphone application (app) suggested that the app was easy to use an

Background: Early warning signs monitoring by service users with schizophrenia has shown promise in preventing relapse but the quality of evidence is low. We aimed to establish the feasibility of undertaking a definitive randomised controlled trial to determine the effectiveness of a blended digital intervention for relapse prevention in schizophrenia. Methods: This multicentre, feasibility, cluster randomised controlled trial aimed to compare Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) with treatment as usual in community mental health services (CMHS) in Glasgow and Melbourne. CMHS were the unit of randomisation, selected on the basis of those that probably had five or more care coordinators willing to participate. Participants were eligible if they were older than 16 years, had a schizophrenia or related diagnosis confirmed via case records, were able to provide informed consent, had contact with CMHS, and had had a relapse within the previous 2 years. Participants were randomised within stratified clusters to EMPOWER or to continue their usual approach to care. EMPOWER blended a smartphone for active monitoring of early warning signs with peer support to promote self-management and clinical triage to promote access to relapse prevention. Main outcomes were feasibility, acceptability, usability, and safety, which was assessed through face-to-face interviews. App usage was assessed via the smartphone and self-report. Primary end point was 12 months. Participants, research assistants and other team members involved in delivering the intervention were not masked to treatment conditions. Assessment of relapse was done by an independent adjudication panel masked to randomisation group. The study is registered at ISRCTN (99559262). Findings: We identified and randomised eight CMHS (six in Glasgow and two in Melbourne) comprising 47 care coordinators. We recruited 86 service users between Jan 19 and Au

BACKGROUND: Early warning signs monitoring by service users with schizophrenia has shown promise in preventing relapse but the quality of evidence is low. We aimed to establish the feasibility of undertaking a definitive randomised controlled trial to determine the effectiveness of a blended digital intervention for relapse prevention in schizophrenia. METHODS: This multicentre, feasibility, cluster randomised controlled trial aimed to compare Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) with treatment as usual in community mental health services (CMHS) in Glasgow and Melbourne. CMHS were the unit of randomisation, selected on the basis of those that probably had five or more care coordinators willing to participate. Participants were eligible if they were older than 16 years, had a schizophrenia or related diagnosis confirmed via case records, were able to provide informed consent, had contact with CMHS, and had had a relapse within the previous 2 years. Participants were randomised within stratified clusters to EMPOWER or to continue their usual approach to care. EMPOWER blended a smartphone for active monitoring of early warning signs with peer support to promote self-management and clinical triage to promote access to relapse prevention. Main outcomes were feasibility, acceptability, usability, and safety, which was assessed through face-to-face interviews. App usage was assessed via the smartphone and self-report. Primary end point was 12 months. Participants, research assistants and other team members involved in delivering the intervention were not masked to treatment conditions. Assessment of relapse was done by an independent adjudication panel masked to randomisation group. The study is registered at ISRCTN (99559262). FINDINGS: We identified and randomised eight CMHS (six in Glasgow and two in Melbourne) comprising 47 care coordinators. We recruited 86 service users between Jan 19 and Au

BACKGROUND: Behavioural sleep problems are common in children with autism spectrum disorder (ASD); however, evidence for the efficacy of behavioural sleep interventions is limited. This study examined the efficacy of a brief behavioural sleep intervention in autistic children. It was hypothesised that the intervention would reduce overall child sleep problems (primary outcome), in addition to improvements in children's social, emotional, cognitive, academic functioning, and quality of life, and parent/caregivers' stress, quality of life, and mental health (secondary outcomes). METHODS: A randomised controlled trial was conducted with participants randomised via a computer-generated sequence to the sleeping sound intervention (n = 123) or treatment as usual (n = 122) group. Participants comprised 245 children with an ASD diagnosis. Inclusion criteria were as follows: confirmation of DSM IV or DSM-5 diagnosis of ASD, participants aged between 5 and 13 years and parent/caregiver report of moderate-severe sleep problems. Exclusion criteria were as follows: parent/caregiver intellectual disability or lacking sufficient English to complete questionnaires; and child participant with co-occurring medical conditions known to impact sleep. The intervention group received the sleeping sound intervention (2 × 50-min face-to-face sessions plus follow-up phone call) by a trained clinician. RESULTS: Change in children's sleep problems was measured by the Children's Sleep Habits Questionnaire (CSHQ) at 3 months post randomisation. Parents/caregivers of children in the intervention group reported a reduction in child sleep problems at 3 months post randomisation (effect size: E.S -0.7). There were also small effects in a number of child (internalising symptoms, emotional behavioural disturbance and quality of life) and parent/caregiver (mental health, parenting stress and quality of life) outcomes; however, these did not remain significant when controlling for multiple comparisons.

IMPORTANCE: Installation of barriers has been shown to reduce suicides. To our knowledge, no studies have evaluated the cost-effectiveness of installing barriers at multiple bridge and cliff sites where suicides are known to occur. OBJECTIVE: To examine the cost-effectiveness of installing barriers at bridge and cliff sites throughout Australia. DESIGN, SETTING, AND PARTICIPANTS: This economic evaluation used an economic model to examine the costs, costs saved, and reductions in suicides if barriers were installed across identified bridge and cliff sites over 5 and 10 years. Specific and accessible bridge and cliff sites across Australia that reported 2 or more suicides over a 5-year period were identified for analysis. A partial societal perspective (including intervention costs and monetary value associated with preventing suicide deaths) was adopted in the development of the model. INTERVENTIONS: Barriers installed at bridge and cliff sites. MAIN OUTCOMES AND MEASURES: Primary outcome was return on investment (ROI) comparing cost savings with intervention costs. Secondary outcomes included incremental cost-effectiveness ratio (ICER), comprising the difference in costs between installation of barriers and no installation of barriers divided by the difference in reduction of suicide cases. Uncertainty and sensitivity analyses were undertaken to examine the association of changes in suicide rates with barrier installation, adjustments to the value of statistical life, and changes in maintenance costs of barriers. RESULTS: A total of 7 bridges and 19 cliff sites were included in the model. If barriers were installed at bridge sites, an estimated US $145 million (95% uncertainty interval [UI], $90 to $160 million) could be saved in prevented suicides over 5 years, and US $270 million (95% UI, $176 to $298 million) over 10 years. The estimated ROI ratio for building barriers over 10 years at bridges was 2.4 (95% UI, 1.5 to 2.7); the results for cliff sites were not sig

BACKGROUND: Approximately one fifth of Australian males aged 16+ experience mood, anxiety or substance use disorders in a given year, and suicide by males accounts for three quarters of all suicides annually. However, males with mental health problems are less likely to seek and receive help than their female counterparts. Media campaigns with videos at their core are gaining popularity as a means of promoting help-seeking for mental health difficulties, but few studies have rigorously tested the impact of such videos. This randomised controlled trial tests the effectiveness of a short video promoting help-seeking by Australian men. METHODS: This study is an online randomised controlled trial (RCT). Participants will attend an online group orientation session, where they will provide consent to participate and complete a baseline questionnaire (T1). After completion of the T1 questionnaire, participants will be randomised to watch either the intervention or control video on a 1:1 basis. After randomisation, participants will be able to access their allocated video for 1 week. Seven days after T1, participants will again be sent links to the video and to the post-exposure questionnaire (T2). One month after T2, participants will be emailed the follow-up questionnaire (T3). The primary outcome will be change in help-seeking intentions from T1 to T2. Secondary outcomes will be changes in help-seeking intentions from T1 to T3, changes in intentions to encourage other males to seek help, self-reliance, and male depression symptoms from T1 to T2 and from T1 to T3. The cost-effectiveness of the intervention will be evaluated. Participants will also complete questions about their opinions of the video and its effects at T2 and T3. DISCUSSION: Our video-based intervention is designed to promote help-seeking for mental health difficulties among Australian men. If a lack of net harm is shown to be associated with viewing the intervention video, the video will be publicly relea

INTRODUCTION: Fear of cancer recurrence (FCR) is a common condition among cancer survivors that can lead to significant levels of distress, anxiety and depression. Online mindfulness programmes may provide the mechanism to support cancer survivors manage FCR and distress, and improve people's well-being over the short, medium and long term. The primary aim of this study is to determine the potential efficacy of MindOnLine, a 9 session mindfulness-based programme for survivors of breast, prostate and colorectal cancer. A formal economic programme will also be conducted. METHODS AND ANALYSIS: A single-blind randomised controlled trial to determine the efficacy and cost-efficacy of a MindOnLine programme for cancer survivors. A total of 400 people living with cancer will be recruited via online advertisements on social media platforms, peak consumer advocacy groups or through outpatient services at healthcare providers across Victoria, Australia. People will be randomly allocated to either the MindOnLine programme (n=200) or waitlist control (n=200). Participant assessments will occur at baseline, at 9 weeks and 9-month follow-up. The primary outcome is change in Fear of Recurrence Index Score total score between baseline and 9 weeks; secondary outcomes are changes in depression and anxiety, quality of life and mindfulness. The economic analysis comprises a cost-consequences analysis where all outcomes will be compared with costs. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Peter MacCallum Cancer Centre (20-53) and Deakin University (2020-284). All participants will be required to provide written informed consent. Findings will be disseminated in peer reviewed journals and among key stakeholder organisations including hospitals, cancer and community organisations and Government. If successful the project will be rolled out nationally with a formal implementation plan. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (126200

BACKGROUND: Suicide is the leading cause of death among young Australians, accounting for one-third of all deaths in those under 25. Schools are a logical setting for youth suicide prevention activities, with universal, selective and indicated approaches all demonstrating efficacy. Given that international best practice recommends suicide prevention programmes combine these approaches, and that to date this has not been done in school settings, this study aims to evaluate a suicide prevention programme incorporating universal, selective and indicated components in schools. METHODS: This study is a trial of a multimodal suicide prevention programme for young people. The programme involves delivering universal psychoeducation (safeTALK) to all students, screening them for suicide risk, and delivering internet-based Cognitive Behavioural Therapy (Reframe IT) to those students identified as being at high risk for suicide. The programme will be trialled in secondary schools in Melbourne, Australia, and target year 10 students (15 and 16 year-olds). safeTALK and screening will be evaluated using a single group pre-test/post-test case series, and Reframe IT will be evaluated in a Randomised Controlled Trial. The primary outcome is change in suicidal ideation; other outcomes include help-seeking behaviour and intentions, and suicide knowledge and stigma. The programme's cost-effectiveness will also be evaluated. DISCUSSION: This study is the first to evaluate a suicide prevention programme comprising universal, selective and indicated components in Australian schools. If the programme is found to be efficacious and cost-effective, it could be more widely disseminated in schools and may ultimately lead to reduced rates of suicide and suicidal behaviour in school students across the region.

BACKGROUND: Public health advocates have highlighted internalising problems as a leading cause of global burden of disease. Internalising problems (anxiety/depression) affect up to 20% of school-age children and can impact peer relations, school engagement and later employment and mortality. This translational trial aimed to determine whether a selective/indicated parenting group programme to prevent internalising distress in shy/inhibited preschool children had sustained effects in middle childhood. Translational design aspects were a brief parent-report screening tool for child inhibition offered universally across the population via preschools in the year before school, followed by an invitation to parents of all inhibited children to attend the parenting programme at venues in their local community. METHODS: Design of the study was a randomised controlled trial. The setting was 307 preschool services across eight socioeconomically diverse government areas in Melbourne, Australia. Participants were 545 parents of inhibited four-year-old children of which 456 (84%) were retained during middle childhood (age of seven to 10 years). Early intervention was the Cool Little Kids parenting group programme, and control was 'usual care' access to available support services in the community. Primary outcomes were child anxiety and depression symptoms (parent and child report) and DSM-IV anxiety disorders (assessor masked). Secondary outcomes were parenting practices and parent mental health. RESULTS: There was no significant difference in anxiety disorders between the intervention and control group during the three annual follow-ups of the cohort in middle childhood (2015 43% vs. 41%, 2016 40% vs. 36%, 2017 27% vs. 30%, respectively; p's > .05). There were also no significant differences in child anxiety or depression symptoms (by child or parent report), parenting practices or parent mental health, between the intervention and control group during middle childhood. However

BACKGROUND: No biological treatment has been firmly established for the at-risk stage of psychotic disorder. In this study we aim to test if subthreshold psychotic symptoms can be effectively treated with cannabidiol (CBD), a non-psychoactive compound of the plant Cannabis sativa. The question has taken on increased importance in the wake of evidence questioning both the need and efficacy of specific pharmacological interventions in the ultra-high risk (UHR) for psychosis group. METHODS: Three-arm randomized controlled trial of 405 patients (135 per arm) aged 12-25 years who meet UHR for psychosis criteria. The study includes a 6-week lead-in phase during which 10% of UHR individuals are expected to experience symptom remission. Participants will receive CBD (per oral) at doses 600 or 1000 mg per day (fixed schedule) for 12 weeks. Participants in the third arm of the trial will receive matching placebo capsules. Primary outcome is severity of positive psychotic symptoms as measured by the Comprehensive Assessment of At-Risk Mental States at 12 weeks. We hypothesize that CBD will be significantly more effective than placebo in improving positive psychotic symptoms in UHR patients. All participants will also be followed up 6 months post baseline to evaluate if treatment effects are sustained. CONCLUSION: This paper reports on the rationale and protocol of the Cannabidiol for At Risk for psychosis Youth (CanARY) study. This study will test CBD for the first time in the UHR phase of psychotic disorder.

BACKGROUND: Males in Australia and many other countries account for three-quarters of all deaths by suicide. School-based programs to support young men's wellbeing have become increasingly common in recent years and show much promise to tackle the issue of male suicide by fostering protective factors and mitigating harmful factors. However, only a few of these programs have been evaluated. This trial seeks to address the lack of knowledge about the potential for school-based gender-transformative programs to have a positive impact on boys. Breaking the Man Code workshops, delivered by Tomorrow Man in Australia, challenge and transform harmful masculinities with young men with a view to ultimately reducing their suicide risk. The trial aims to examine whether adolescent boys who participate in the Breaking the Man Code workshop demonstrate an increase in their likelihood of seeking help for personal or emotional problems compared to boys waiting to take part in the workshop. METHODS: A stratified cluster randomized controlled superiority trial with two parallel groups will be conducted. Schools will be randomly allocated 1:1, stratified by location of the schools (rural or urban), state (Victoria, NSW, or WA), and mode of workshop delivery (face-to-face or online), to the intervention group and waitlist control group. DISCUSSION: The Breaking the Man Code workshops show great promise as a school-based prevention intervention. The trial will fill a gap in knowledge that is critically needed to inform future interventions with boys and men. Some methodological challenges have been identified related to the COVID-19 pandemic in Australia, such as delays in ethics approvals and the need for Tomorrow Man to introduce an online delivery option for the workshop. The trial protocol has been designed to mitigate these challenges. The findings from the trial will be used to improve the workshops and will assist others who are designing and implementing suicide prevention inter

BACKGROUND: Older Australians make up 46% of all potentially preventable hospitalisations (PPHs) and people living with dementia are at significantly greater risk. While policy reforms aim to reduce PPHs, there is currently little evidence available on what drives this, especially for people living with dementia. This study examines patterns of PPHs in people living with dementia to inform service delivery and the development of evidence-based interventions. METHODS: We used the Victorian Admitted Episodes Dataset from Victoria, Australia, to extract data for people aged 50 and over with a diagnosis of dementia between 2015 and 2016. Potentially avoidable admissions, known as ambulatory care sensitive conditions (ACSCs), were identified. The chi-square test was used to detect differences between admissions for ACSCs and non-ACSCs by demographic, geographical, and administrative factors. Predictors of ACSCs admissions were analysed using univariate and multiple logistic regression. RESULTS: Of the 8156 hospital records, there were 3884 (48%) ACSCs admissions, of which admissions for urinary tract infections accounted for 31%, followed by diabetes complications (21%). Mean bed-days were 8.26 for non-ACSCs compared with 9.74 for ACSCs (p ≤ 0.001). There were no differences between admissions for ACSCs and non-ACSCs by sex, marital status, region (rural vs metro), and admission source (private accommodation vs residential facility). Culture and language predicted ASCS admission rates in the univariate regression analyses, with ACSC admission rates increasing by 20 and 29% if English was not the preferred language or if an interpreter was required, respectively. Results from the multiple regression analysis confirmed that language was a significant predictor of ACSC admission rates. CONCLUSIONS: Improved primary health care may help to reduce the most common causes of PPHs for people living with dementia, particularly for those from culturally and linguistically diverse

AIMS: The utility of quality of life (QoL) as an outcome measure in youth-specific primary mental health care settings has yet to be determined. We aimed to determine: (i) whether heterogeneity on individual items of a QoL measure could be used to identify distinct groups of help-seeking young people; and (ii) the validity of these groups based on having clinically meaningful differences in demographic and clinical characteristics. METHODS: Young people, at their first presentation to one of five primary mental health services, completed a range of questionnaires, including the Assessment of Quality of Life-6 dimensions adolescent version (AQoL-6D). Latent class analysis (LCA) and multivariate multinomial logistic regression were used to define classes based on AQoL-6D and determine demographic and clinical characteristics associated with class membership. RESULTS: 1107 young people (12-25 years) participated. Four groups were identified: (i) no-to-mild impairment in QoL; (ii) moderate impairment across dimensions but especially mental health and coping; (iii) moderate impairment across dimensions but especially on the pain dimension; and (iv) poor QoL across all dimensions along with a greater likelihood of complex and severe clinical presentations. Differences between groups were observed with respect to demographic and clinical features. CONCLUSIONS: Adding multi-attribute utility instruments such as the AQoL-6D to routine data collection in mental health services might generate insights into the care needs of young people beyond reducing psychological distress and promoting symptom recovery. In young people with impairments across all QoL dimensions, the need for a holistic and personalised approach to treatment and recovery is heightened.

This study examined the sustained and moderating effects of a behavioural sleep intervention for autistic children in a randomised controlled trial. Autistic children (5-13 years) with sleep problems were randomised to the Sleeping Sound intervention or Treatment as Usual (TAU). At 12-month follow-up (n = 150), caregivers of children in the Sleeping Sound group reported greater reduction in child sleep problems compared to TAU (p < .001, effect size: - 0.4). The long-term benefits of the intervention were greater for children taking sleep medication, children of parents who were not experiencing psychological distress, and children with greater autism severity. The Sleeping Sound intervention demonstrated sustained improvements in child sleep. Identified moderators may inform treatment by indicating which subgroups may benefit from further support.

BACKGROUND: Target-D, a new person-centred e-health platform matching depression care to symptom severity prognosis (minimal/mild, moderate or severe) has demonstrated greater improvement in depressive symptoms than usual care plus attention control. The aim of this study was to evaluate the cost-effectiveness of Target-D compared to usual care from a health sector and partial societal perspective across 3-month and 12-month follow-up. METHODS AND FINDINGS: A cost-utility analysis was conducted alongside the Target-D randomised controlled trial; which involved 1,868 participants attending 14 general practices in metropolitan Melbourne, Australia. Data on costs were collected using a resource use questionnaire administered concurrently with all other outcome measures at baseline, 3-month and 12-month follow-up. Intervention costs were assessed using financial records compiled during the trial. All costs were expressed in Australian dollars (A$) for the 2018-19 financial year. QALY outcomes were derived using the Assessment of Quality of Life-8D (AQoL-8D) questionnaire. On a per person basis, the Target-D intervention cost between $14 (minimal/mild prognostic group) and $676 (severe group). Health sector and societal costs were not significantly different between trial arms at both 3 and 12 months. Relative to a A$50,000 per QALY willingness-to-pay threshold, the probability of Target-D being cost-effective under a health sector perspective was 81% at 3 months and 96% at 12 months. From a societal perspective, the probability of cost-effectiveness was 30% at 3 months and 80% at 12 months. CONCLUSIONS: Target-D is likely to represent good value for money for health care decision makers. Further evaluation of QALY outcomes should accompany any routine roll-out to assess comparability of results to those observed in the trial. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616000537459).

BACKGROUND: Although the proportion of men seeking professional mental health care has risen over the past two decades, on average, men continue to attend fewer sessions of psychotherapy and are more likely to drop out of treatment prematurely compared to women. Men account for three-quarters of suicide deaths; furthermore, over half of the males who die by suicide have engaged with mental health care in the 12 months prior to their death. These findings highlight a need to equip mental health practitioners with skills to improve male clients' engagement and mental health outcomes. This article reports the protocol for a randomized controlled trial of Men in Mind, a self-paced online training program purpose-built to advance the clinical competencies of practitioners who provide psychotherapy to male clients. METHODS: A randomized controlled trial with two parallel groups will be conducted. Participating practitioners will be randomly allocated, on a 1:1 basis, to the intervention group (Men in Mind training) or a waitlist control group. The primary outcome, efficacy of the training, will be evaluated by pre- to post-training (T1 to T2) changes in scores on the Engaging Men in Therapy Scale (EMITS) in the intervention group, relative to the control group. DISCUSSION: This trial will provide evidence of the efficacy of Men in Mind training, as an interim step towards adjusting content and delivery of the intervention to maximize the potential for sustaining and scaling. TRIAL REGISTRATION: The trial was registered prospectively with the Australian New Zealand Clinical Trials Registry on 3rd December 2021 (ACTRN12621001669886).

BACKGROUND: This paper reports on the cost-effectiveness evaluation of Link-me - a digitally supported, systematic approach to triaging care for depression and anxiety in primary care that uses a patient-completed Decision Support Tool (DST). METHODS: The economic evaluation was conducted alongside a parallel, stratified individually randomised controlled trial (RCT) comparing prognosis-matched care to usual care at six- and 12-month follow-up. Twenty-three general practices in three Australian Primary Health Networks recruited 1,671 adults (aged 18 - 75 years), predicted by the DST to have minimal/mild or severe depressive or anxiety symptoms in three months. The minimal/mild prognostic group was referred to low intensity services. Participants screened in the severe prognostic group were offered high intensity care navigation, a model of care coordination. The outcome measures included in this evaluation were health sector costs (including development and delivery of the DST, care navigation and other healthcare services used) and societal costs (health sector costs plus lost productivity), psychological distress [Kessler Psychological Distress Scale (K10)] and quality adjusted life years (QALYs) derived from the EuroQol 5-dimension quality of life questionnaire with Australian general population preference weights applied. Costs were valued in 2018-19 Australian dollars (A$). RESULTS: Across all participants, the health sector incremental cost-effectiveness ratio (ICER) of Link-me per point decrease in K10 at six months was estimated at $1,082 (95% CI $391 to $6,204) increasing to $2,371 (95% CI $191 to Dominated) at 12 months. From a societal perspective, the ICER was estimated at $1,257/K10 point decrease (95% CI Dominant to Dominated) at six months, decreasing to $1,217 (95% CI Dominant to Dominated) at 12 months. No significant differences in QALYs were detected between trial arms and the intervention was dominated (less effective, more costly) based on the c

INTRODUCTION: Media guidelines for the responsible reporting of suicide are a recognized universal suicide prevention intervention. While implemented in numerous countries, including Australia, little is known about whether they are cost-effective. We aimed to determine the cost-effectiveness of Mindframe, the national initiative implementing media guidelines in Australia. METHOD: We conducted a modelled economic evaluation (5-year time-horizon) incorporating two types of economic analysis: (i) return-on-investment (ROI) comparing estimated cost savings from the intervention to the total intervention cost, and (ii) cost-effectiveness analysis comparing the net intervention costs to health outcomes: suicide deaths prevented and quality-adjusted life-years (QALYs). We also included uncertainty analyses to propagate parameter uncertainty and sensitivity analyses to test the robustness of the model outputs to changes in input parameters and assumptions. RESULTS: The estimated ROI ratio for the main analysis was 94:1 (95% uncertainty interval [UI]: 37 to 170). The intervention was associated with cost savings of A$596M (95% UI: A$228M to A$1,081M), 139 (95% UI: 55 to 252) suicides prevented and 107 (95% UI: 42 to 192) QALYs gained. The intervention was dominant, or cost-saving, compared with no intervention with results being robust to sensitivity analysis but varying based on the conservativeness of the parameters entered. CONCLUSION: Mindframe was found to be cost-saving, and therefore, worthy of investment and inclusion as part of national suicide prevention strategies.

Males are at higher risk of death by suicide than females in Australia, and among men, blue-collar males are at higher risk compared to other working males. In response, MATES in Construction developed a workplace suicide prevention program for the construction sector in 2007 that has been widely implemented in Australia. In the current project, this program is being adapted and trialled in the manufacturing sector. The common aims of MATES programs are to improve suicide prevention literacy, help-seeking intentions, and helping behaviours. The program will be evaluated using a cluster randomised-controlled trial design with waitlist controls across up to 12 manufacturing worksites in Australia. We hypothesise that after 8 months of the MATES in Manufacturing program, there will be significantly greater improvements in help-seeking intentions (primary outcome) compared to waitlist controls. The project is led by Deakin University in collaboration with the University of Melbourne, and in partnership with MATES in Construction and a joint labour-management Steering Group.Trial registration: The trial was registered retrospectively with the Australian New Zealand Clinical Trials Registry on 25 January 2022 (ACTRN12622000122752).Protocol version: 2.0, November 2022.

Objective: In Victoria, Prevention and Recovery Care Services have been established to provide a partial alternative to inpatient admissions through short-term residential mental health care in the community. This study set out to determine whether Prevention and Recovery Care Services are achieving their objectives in relation to reducing service use and costs, fostering least restrictive care and leading to positive clinical outcomes. Method(s): We matched 621 consumers whose index admission in 2014 was to a Prevention and Recovery Care ('PARCS consumers') with 621 similar consumers whose index admission in the same year was to an acute inpatient unit and who had no Prevention and Recovery Care stays for the study period ('inpatient-only consumers'). We used routinely collected data to compare them on a range of outcomes. Result(s): Prevention and Recovery Care Services consumers made less subsequent use of acute inpatient services and, on balance, incurred costs that were similar to or lower than inpatient-only consumers. They were also less likely to spend time on an involuntary treatment order following their index admission. Prevention and Recovery Care Services consumers also experienced positive clinical outcomes over the course of their index admission, but the magnitude of this improvement was not as great as for inpatient-only consumers. This type of clinical improvement is important for Prevention and Recovery Care Services, but they may place greater emphasis on personal recovery as an outcome. Conclusion(s): Prevention and Recovery Care Services can provide an alternative, less restrictive care option for eligible consumers who might otherwise be admitted to an acute inpatient unit and do so at no greater cost.Copyright © The Royal Australian and New Zealand College of Psychiatrists 2021.

BACKGROUND: The volume and heterogeneity of mental health problems that primary care patients present with is a substantial challenge for health systems, and both undertreatment and overtreatment are common. We developed Link-me, a patient-completed Decision Support Tool, to predict severity of depression or anxiety, identify priorities, and recommend interventions. In this study, we aimed to examine if Link-me reduces psychological distress among individuals predicted to have minimal/mild or severe symptoms of anxiety or depression. METHODS: In this pragmatic stratified randomised controlled trial, adults aged 18-75 years reporting depressive or anxiety symptoms or use of mental health medication were recruited from 23 general practices in Australia. Participants completed the Decision Support Tool and were classified into three prognostic groups (minimal/mild, moderate, severe), and those in the minimal/mild and severe groups were eligible for inclusion. Participants were individually and randomly assigned (1:1) by a computer-generated allocation sequence to receive either prognosis-matched care (intervention group) or usual care plus attention control (control group). Participants were not blinded but intervention providers were only notified of those allocated to the intervention group. Outcome assessment was blinded. The primary outcome was the difference in the change in scores between the intervention and control group, and within prognostic groups, on the 10-item Kessler Psychological Distress Scale at 6 months post randomisation. The trial was registered on the Australian and New Zealand Clinical Trials Registry, ACTRN12617001333303. OUTCOMES: Between Nov 21, 2017, and Oct 31, 2018, 24 616 patients were invited to complete the eligibility screening survey. 1671 of these patients were included and randomly assigned to either the intervention group (n=834) or the control group (n=837). Prognosis-matched care was associated with greater reductions in psycholog

OBJECTIVE: In Victoria, Prevention and Recovery Care Services have been established to provide a partial alternative to inpatient admissions through short-term residential mental health care in the community. This study set out to determine whether Prevention and Recovery Care Services are achieving their objectives in relation to reducing service use and costs, fostering least restrictive care and leading to positive clinical outcomes. METHODS: We matched 621 consumers whose index admission in 2014 was to a Prevention and Recovery Care ('PARCS consumers') with 621 similar consumers whose index admission in the same year was to an acute inpatient unit and who had no Prevention and Recovery Care stays for the study period ('inpatient-only consumers'). We used routinely collected data to compare them on a range of outcomes. RESULTS: Prevention and Recovery Care Services consumers made less subsequent use of acute inpatient services and, on balance, incurred costs that were similar to or lower than inpatient-only consumers. They were also less likely to spend time on an involuntary treatment order following their index admission. Prevention and Recovery Care Services consumers also experienced positive clinical outcomes over the course of their index admission, but the magnitude of this improvement was not as great as for inpatient-only consumers. This type of clinical improvement is important for Prevention and Recovery Care Services, but they may place greater emphasis on personal recovery as an outcome. CONCLUSION: Prevention and Recovery Care Services can provide an alternative, less restrictive care option for eligible consumers who might otherwise be admitted to an acute inpatient unit and do so at no greater cost.

BACKGROUND: Mental health treatment rates are increasing, but the burden of disease has not reduced. Tools to support efficient resource distribution are required. AIM: To investigate whether a person-centred e-health (Target-D) platform matching depression care to symptom severity prognosis can improve depressive symptoms relative to usual care. DESIGN AND SETTING: Stratified individually randomised controlled trial in 14 general practices in Melbourne, Australia, from April 2016 to February 2019. In total, 1868 participants aged 18-65 years who had current depressive symptoms; internet access; no recent change to antidepressant; no current antipsychotic medication; and no current psychological therapy were randomised (1:1) via computer-generated allocation to intervention or usual care. METHOD: The intervention was an e-health platform accessed in the GP waiting room, comprising symptom feedback, priority-setting, and prognosis-matched management options (online self-help, online guided psychological therapy, or nurse-led collaborative care). Management options were flexible, neither participants nor staff were blinded, and there were no substantive protocol deviations. The primary outcome was depressive symptom severity (9-item Patient Health Questionnaire [PHQ-9]) at 3 months. RESULTS: In intention to treat analysis, estimated between- arm difference in mean PHQ-9 scores at 3 months was -0.88 (95% confidence interval [CI] = -1.45 to -0.31) favouring the intervention, and -0.59 at 12 months (95% CI = -1.18 to 0.01); standardised effect sizes of -0.16 (95% CI = -0.26 to -0.05) and -0.10 (95% CI = -0.21 to 0.002), respectively. No serious adverse events were reported. CONCLUSION: Matching management to prognosis using a person-centred e-health platform improves depressive symptoms at 3 months compared to usual care and could feasibly be implemented at scale. Scope exists to enhance the uptake of management options.

BACKGROUND: The aim was to determine outcomes in the first year of school of a population-delivered parenting program to prevent internalising problems in temperamentally inhibited preschool children and predictors of engagement in parenting groups. METHOD: Design: Randomised controlled trial. SETTING: 307 preschool services across eight socio-economically diverse government areas in Melbourne, Australia. PARTICIPANTS: 545 parents of inhibited 4-year-old children; 469 (86%) retained at two-year follow-up. INTERVENTION: Cool Little Kids program. Primary outcomes were child internalising symptoms and anxiety disorders. Secondary outcomes were parenting, parent well-being and engagement. Trial registration ISRCTN30996662 http://www.isrctn.com/ISRCTN30996662. RESULTS: In the first year of school (M (SD) age 6.7 (0.4) years), child anxiety symptoms were reduced in the intervention versus control arm (PAS-R M (SD): total 36.2 (17.2) versus 39.4 (18.5); adjusted difference -3.26, 95% CI -6.46 to -0.05, p = .047; specific fears 9.1 (6.2) versus 10.7 (6.8), adjusted difference -1.53; 95% CI -2.69 to -0.38, p = .009). However, there was little difference in broader child internalising (CMFWQ M (SD): 2.2 (0.5) versus 2.3 (0.6); adjusted difference -0.03, 95% CI -0.13 to 0.06, p = .489) or anxiety disorders (37.6% vs. 42.6%; adjusted OR 0.79, 95% CI 0.53 to 1.18, p = .242). Lower income, younger mothers, less educated and more culturally diverse fathers engaged less with the intervention. Continued skills practice was less frequent for parents of girls and in advantaged neighbourhoods. CONCLUSIONS: There were population effects of Cool Little Kids in the first year of school for anxiety symptoms but not disorders. Considering motivation techniques to engage subgroups of families would be helpful in translation research.

This study aimed to determine whether, following two years of specialized support for first-episode psychosis, the addition of a new digital intervention (Horyzons) to treatment as usual (TAU) for 18 months was more effective than 18 months of TAU alone. We conducted a single-blind randomized controlled trial. Participants were people with first-episode psychosis (N=170), aged 16-27 years, in clinical remission and nearing discharge from a specialized service. They were randomly assigned (1:1) to receive Horyzons plus TAU (N=86) or TAU alone (N=84) between October 2013 and January 2017. Horyzons is a novel, comprehensive digital platform merging: peer-to-peer social networking; theory-driven and evidence-informed therapeutic interventions targeting social functioning, vocational recovery and relapse prevention; expert clinician and vocational support; and peer support and moderation. TAU involved transfer to primary or tertiary community mental health services. The primary outcome was social functioning at 18 months as measured by the Personal and Social Performance Scale (PSP). Forty-seven participants (55.5%) in the Horyzons plus TAU group logged on for at least 6 months, and 40 (47.0%) for at least 9 months. Social functioning remained high and stable in both groups from baseline to 18-month follow-up, with no evidence of significant between-group differences (PSP mean difference: -0.29, 95% CI: -4.20 to 3.63, p=0.77). Participants in the Horyzons group had a 5.5 times greater increase in their odds to find employment or enroll in education compared with those in TAU (odds ratio, OR=5.55, 95% CI: 1.09-28.23, p=0.04), with evidence of a dose-response effect. Moreover, participants in TAU were twice as likely to visit emergency services compared to those in the Horyzons group (39% vs. 19%; OR=0.31, 95% CI: 0.11-0.86, p=0.03, number needed to treat, NNT=5). There was a non-significant trend for lower hospitalizations due to psychosis in the Horyzons group vs. TAU (1

Background Reducing suicides is a key Sustainable Development Goal target for improving global health. Highly hazardous pesticides are among the leading causes of death by suicide in low-income and middle-income countries. National bans of acutely toxic highly hazardous pesticides have led to substantial reductions in pesticide-attributable suicides across several countries. This study evaluated the cost-effectiveness of implementing national bans of highly hazardous pesticides to reduce the burden of pesticide suicides.Methods A Markov model was developed to examine the costs and health effects of implementing a national ban of highly hazardous pesticides to prevent suicides due to pesticide self-poisoning, compared with a null comparator. We used WHO cost-effectiveness and strategic planning (WHO-CHOICE) methods to estimate pesticide-attributable suicide rates for 100 years from 2017. Country-specific costs were obtained from the WHO-CHOICE database and denominated in 2017 international dollars (I$), discounted at a 3% annual rate, and health effects were measured in healthy life-years gained (HLYGs). We used a demographic projection model beginning with the country population in the baseline year (2017), split by 1-year age group and sex. Country-specific data on overall suicide rates were obtained for 2017 by age and sex from the Global Burden of Disease Study 2017 Data Resources. The analysis involved 14 countries spanning low-income to high-income settings, and cost-effectiveness ratios were analysed at the country-specific level and aggregated according to country income group and the proportion of suicides due to pesticides.Findings Banning highly hazardous pesticides across the 14 countries studied could result in about 28 000 (95% uncertainty interval [UI] 24 000-32 000) fewer suicide deaths each year at an annual cost of I$0.007 per capita (95% UI 0.006-0.008). In the population-standardised results for the base case analysis, national ba

Background: Reducing suicides is a key Sustainable Development Goal target for improving global health. Highly hazardous pesticides are among the leading causes of death by suicide in low-income and middle-income countries. National bans of acutely toxic highly hazardous pesticides have led to substantial reductions in pesticide-attributable suicides across several countries. This study evaluated the cost-effectiveness of implementing national bans of highly hazardous pesticides to reduce the burden of pesticide suicides.Methods: A Markov model was developed to examine the costs and health effects of implementing a national ban of highly hazardous pesticides to prevent suicides due to pesticide self-poisoning, compared with a null comparator. We used WHO cost-effectiveness and strategic planning (WHO-CHOICE) methods to estimate pesticide-attributable suicide rates for 100 years from 2017. Country-specific costs were obtained from the WHO-CHOICE database and denominated in 2017 international dollars (I$), discounted at a 3% annual rate, and health effects were measured in healthy life-years gained (HLYGs). We used a demographic projection model beginning with the country population in the baseline year (2017), split by 1-year age group and sex. Country-specific data on overall suicide rates were obtained for 2017 by age and sex from the Global Burden of Disease Study 2017 Data Resources. The analysis involved 14 countries spanning low-income to high-income settings, and cost-effectiveness ratios were analysed at the country-specific level and aggregated according to country income group and the proportion of suicides due to pesticides.Findings: Banning highly hazardous pesticides across the 14 countries studied could result in about 28 000 (95% uncertainty interval [UI] 24 000–32 000) fewer suicide deaths each year at an annual cost of I$0·007 per capita (95% UI 0·006–0·008). In the population-standardised results for the base case an

BACKGROUND: Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. OBJECTIVE: This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. METHODS: We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculat

AIM: To: (1) investigate the relationship between upper-limb impairment and health-related quality of life (HRQoL) for children with cerebral palsy and (2) develop a mapping algorithm from the Cerebral Palsy Quality of Life Questionnaire for Children (CPQoL-Child) onto the Child Health Utility 9D (CHU9D) measure. METHOD: The associations between physical and upper-limb classifications and HRQoL of 76 children (40 females, 36 males) aged 6 to 15 years (mean age 9 years 7 months [SD 3y]) were assessed. Five statistical techniques were developed and tested, which predicted the CHU9D scores from the CPQoL-Child total/domain scores, age, and sex. RESULTS: Most participants had mild impairments. The Manual Ability Classification System (MACS) level was significantly negatively correlated with CHU9D and CPQoL-Child (r=-0.388 and r=-0.464 respectively). There was a negative correlation between the Neurological Hand Deformity Classification (NHDC) and CPQoL-Child (r=-0.476, p<0.05). The generalized linear model with participation, pain domain, and age had the highest predictive accuracy. INTERPRETATION: The weak negative correlations between classification levels and HRQoL measures may be explained by the restricted range of impairment levels of the participants. The MACS and NHDC explained the impact of upper-limb impairment on HRQoL better than the other classifications. The generalized linear model with participation, pain, and age is the suggested mapping algorithm. The suggested mapping algorithm will facilitate the use of CPQoL-Child for economic evaluation and can be used to conduct cost-utility analyses. WHAT THIS PAPER ADDS: The Manual Ability Classification System and Neurological Hand Deformity Classification were the best predictors of health-related quality of life measures. Age and Cerebral Palsy Quality of Life Questionnaire for Children participation and pain domain scores can predict Child Health Utility 9D scores.

The aim of the study was to examine sex differences in self‐reported psychological distress, behavioural and emotional problems, and substance use in young people living in out‐of‐home care (OoHC). One hundred seventy‐six young people aged 12–17 years (females 53.4%) in OoHC in metropolitan Melbourne, Australia, were interviewed. Participants completed self‐report measures: Kessler Psychological Distress Scale, Strengths and Difficulties Questionnaire, and the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test—Youth Version. Girls had more OoHC placement instability over the past year compared with boys (p = .019). Compared with boys, the girls had significantly higher levels of distress (p < .001) (p = .007), were more likely to have self‐reported emotional symptoms (p < .001) and peer relationship problems (p = .043) and were more likely to use sedatives (p = .004). Girls had more psychological distress, behavioural disturbance, and sedative abuse; placement instability might contribute to these problems. Greater integration across OoHC, mental health, and substance use sectors is required. Girls in OoHC may benefit from interventions targeting problems with peer relationship and substance use and supporting prosocial behaviour; such targets may reduce distress and emotional symptoms and possibly prevent longer term problems.

BACKGROUND: Cardiovascular disease (CVD) accounts for 40% of the excess mortality identified in people with severe mental illness (SMI). Modifiable CVD risk factors are higher and can be exacerbated by the cardiometabolic impact of psychotropic medications. People with SMI frequently attend primary care presenting a valuable opportunity for early identification, prevention and management of cardiovascular health. The ACCT Healthy Hearts Study will test a coproduced, nurse-led intervention delivered with general practitioners to reduce absolute CVD risk (ACVDR) at 12 months compared with an active control group. METHODS/DESIGN: ACCT is a two group (intervention/active control) individually randomised (1:1) controlled trial (RCT). Assessments will be completed baseline (pre-randomisation), 6 months, and 12 months. The primary outcome is 5-year ACVDR measured at 12 months. Secondary outcomes include 6-month ACVDR; and blood pressure, lipids, HbA1c, BMI, quality of life, physical activity, motivation to change health behaviour, medication adherence, alcohol use and hospitalisation at 6 and 12 months. Linear mixed-effects regression will estimate mean difference between groups for primary and secondary continuous outcomes. Economic cost-consequences analysis will be conducted using quality of life and health resource use information and routinely collected government health service use and medication data. A parallel process evaluation will investigate implementation of the intervention, uptake and outcomes. DISCUSSION: ACCT will deliver a coproduced and person-centred, guideline level cardiovascular primary care intervention to a high need population with SMI. If successful, the intervention could lead to the reduction of the mortality gap and increase opportunities for meaningful social and economic participation. Trial registration ANZCTR Trial number: ACTRN12619001112156.

Background: The clinical onset of borderline personality disorder (BPD) usually occurs in young people (aged 12–25 years) and commonly leads to difficulty achieving and maintaining vocational (education and/or employment) engagement. While current psychosocial interventions lead to improvements in psychopathology, they have little effect upon functioning. Individual Placement and Support (IPS) is a client-driven model that assists individuals with severe mental illness to engage with education and/or employment appropriate to their personal goals, and that provides ongoing support to maintain this engagement. The objective of the INdividual Vocational and Educational Support Trial (INVEST) is to evaluate the effectiveness of adding IPS to an evidence-based early intervention programme for BPD, with the aim of improving vocational outcomes. Methods/design: INVEST is a single-blind, parallel-groups, randomised controlled trial (RCT). The randomisation is stratified by gender and age and uses random permuted blocks. The interventions are 39 weeks of either IPS, or ‘usual vocational services’ (UVS). Participants will comprise 108 help-seeking young people (aged 15–25 years) with three or more DSM-5 BPD features and a desire to study or work, recruited from the Helping Young People Early (HYPE) early intervention programme for BPD at Orygen, in Melbourne, Australia. All participants will receive the HYPE intervention. After baseline assessment, staff who are blind to the intervention group allocation will conduct assessments at 13, 26, 39 and 52 weeks. At the 52-week primary endpoint, the primary outcome is the number of days in mainstream education/employment since baseline. Secondary outcomes include the cost-effectiveness of the intervention, quality of life, and BPD severity. Discussion: Current treatments for BPD have little impact on vocational outcomes and enduring functional impairment is prevalent among this patient group. IPS is a targeted functional interventi